The American Society of Echocardiography (ASE) will host its 27th Annual Scientific Sessions, June 10-14, 2016, at the Washington State Convention Center in Seattle.

BioVentrix Inc. announced that it has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial, named ALIVE (American Less Invasive Ventricular Enhancement).

Biotronik announced the launch of CardioMessenger Smart in the United States. CardioMessenger Smart is a portable monitoring device, about the size of a modern smartphone, that keeps pacemaker, implantable cardioverter defibrillator (ICD) and insertable cardiac monitor (ICM) patients connected to their physician remotely, enabling more efficient care management anywhere in the world.

A person is admitted to the hospital with a stroke, but not much is known about whether or not that patient will undergo neuroimaging.

In a recent study, the use of a stent to repair pulmonary artery stenosis in children and adults with congenital heart disease was successful in the majority of patients, but many also experienced serious complications. The study was published in March in the Journal of the American College of Cardiology.

MIM Software Inc. announced it has received 510(k) U.S. Food and Drug Administration (FDA) clearance to market full MIM products running on tablets through thin client technology such as Citrix.

Medic Vision Imaging Solutions Ltd. announced the U.S. Food and Drug Administration (FDA) clearance of SafeCT-29 to help healthcare facilities achieve compliance as mandated by NEMA XR-29 Smart Dose standard.


May 27, 2016 — A U.S. Food and Drug Administration (FDA) panel recommended approval of a transcatheter patent foramen ovale (PFO) occluder to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

The FDA’s Circulatory System Devices Panel met May 24 to discuss the merits of a premarket approval (PMA) application for St. Jude Medical’s Amplatzer PFO Occluder System. The panel voted to recommend approval to the FDA, but there were questions about the device and supporting data from several panel members. 



(Watch an  October 2019 update on this article with radial adoption rates nearing 50 percent in the U.S. in the VIDEO: Trends in Radial Access for Percutaneous Coronary Interventions)
 

 


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